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The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373919
First Posted: September 8, 2006
Last Update Posted: March 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaplan Medical Center
  Purpose

Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy.

Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence.

Design: This is a prospective, randomized, double blind, placebo controlled study.

Number of patients: 30.

Inclusion Criteria:

  • Patients after trans-hiatal esophagectomy

Exclusion Criteria:

  • Allergy to erythromycin
  • Use of phenothiazine
  • QT prolongation
  • Liver function test (LFT) abnormalities
  • Myasthenia gravis
  • Cardiomyopathy

Condition Intervention
Esophagectomy Postoperative Complications Drug: intravenous (IV) administration of erythromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients after trans-hiatal esophagectomy

Exclusion Criteria:

  • Allergy to erythromycin
  • Use of phenothiazine
  • QT prolongation
  • Liver function test (LFT) abnormalities
  • Myasthenia gravis
  • Cardiomyopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373919


Contacts
Contact: Yoram Klein, MD 972-50-8213221 yoramkl@clalit.org.il

Sponsors and Collaborators
Kaplan Medical Center
Investigators
Principal Investigator: Koram Klein, MD Kaplan Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00373919     History of Changes
Other Study ID Numbers: erythro-esophagus
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: March 5, 2007
Last Verified: August 2006

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action